Apparatus, system, and method of detecting an analyte utilizing pyroelectric technology

ABSTRACT

A system for the measurement of a target analyte is provided including a detection apparatus and a reading apparatus. The detection apparatus, or “carrier”, includes a pyroelectric transducer (“pyroelectric film”) and one or more reagent concentrations (“reagent deposit”) deposited on the film. The reagent deposits are adapted to react with, and thus, detect the presence of a target analyte present in the local environment. Upon detection of the target analyte by the reagent deposit, the reading apparatus and the pyroelectric film may be used to detect the amount of heat that can be absorbed by the reagent deposit in response to irradiation. The pyroelectric film then delivers to the reader a signal corresponding to heat detected and the reader provides a corresponding indication of the concentration of the target substance detected.

This application claims priority from U.S. Provisional PatentApplication Ser. No. 60/540,308 filed on Jan. 29, 2004.

The patent application did not receive federal research and developmentfunds.

BACKGROUND OF THE INVENTION

The present invention relates generally to an apparatus, system, andmethod of detecting a target substance, i.e., an analyte, such as a gas,in a local environment. More particularly, the invention is such asystem, apparatus, and method that employs or incorporates pyroelectricor piezoelectric technology.

It is often desirable, advantageous, or simply necessary to monitor theenvironment around a work place, home or other sites. For example, inmany industrial environments, hazards may exist in the form of toxic,carcinogen, flammable, corrosive chemicals and harmful, radiochemicaland biological materials. This is especially a concern when the harmfulchemicals or substances are not readily detectable, e.g., odorless orinvisible to the human senses. These environments may be constantlymonitored by safety personnel equipped with portable testing equipment,including gas detectors, other instruments, water kits, radiationdetectors, other instruments for detecting biological materials andother harmful chemicals and contaminants. Alternatively, personnel maybe required to wear or carry field detection devices, such as badges,that provide an observable alarm when certain levels of the harmfulchemicals are detected. In addition, monitoring equipment may bepermanently placed at strategic locations to alert personnel ofdangerous conditions, or the presence of pollutants and contaminants.

The present invention is related to systems, apparatus and methodsdescribed in U.S. Provisional Application No. 60/306,469, filed Jul. 18,2001, International Application PCT/US02/23309 filed Jul. 18, 2002, andU.S. patent application Ser. No. 10/475,157, filed Oct. 15, 2003. Eachof these applications is hereby incorporated by reference and made apart of the present disclosure for background purposes. Theabove-described applications are just some of the applications in whichthe present invention and its various aspects may be suited for use. Itshould be understood, however, that terms used to describe the presentinvention and certain embodiments and aspects of the present inventionare adequately defined and explained herein and may possibly deviate orexpand, by Applicants' choice, from earlier definitions and explanationsfor purposes relevant to only to the present description (and thus,should not impact any reading and/or interpretation of these earlierfiled applications).

SUMMARY OF THE INVENTION

In one aspect of the present invention, a system for the measurement ofa target analyte is provided. The system includes a detection apparatusand a reading apparatus. The detection apparatus, or “carrier”, includesa pyroelectric or piezoelectric transducer (hereinafter “pyroelectricfilm”) and one or more reagent concentrations (“reagent deposits”)deposited on (or on a separate substrate in the vicinity of) the filmand adapted to react with, and thus, detect the presence of a targetanalyte in the local environment. The reagent deposit is further adaptedto exposure to an electromagnetic emitting source. The pyroelectric filmdetects the light absorption of the reagent deposit as microscopicheating. This microscopic heating produces an output that is processedto derive the measurement of the target substance. In this manner, thepyroelectric film is used to indicate the amount of or concentration ofthe target analyte in the environment. U.S. Pat. No. 5,622,868 describestechnology that is related to and at least partly applicable to theinvention, and thus, hereby incorporated by reference for all purposesand made part of the present disclosure.

A reading apparatus is provided that is operable with a detectionapparatus described above. Such a reading apparatus includes anelectromagnetic emitting source (e.g., light emitting diode (LED)) thatis operable with the pyroelectric film and a reagent deposit to indicatethe amount or concentration of the target analyte. The reading apparatusand the detection apparatus may be two distinct devices or may beincorporated into a single device. The electromagnetic source may beoptionally mounted on a removable, modular subassembly such that it canbe interchanged to provide the optimum energy source for theapplication.

As used herein, the term “indication” or “indicating” shall meanmeasuring, monitoring, or otherwise communicating the detection of thetarget substance to the user in a quantitative and/or qualitativemanner, including the measurement and display of the amount orconcentration of the target substance in the local environment or thedetection of a specified amount or concentration of the targetsubstance. Such communication may be performed visually, audibly, or bytactile sense. Also, as used herein, a “reagent deposit” shall mean aconcentration of reagent applied to a surface and shall not be limitedto any specific shape, form, quantity, concentration or substance.

One system according to the invention will include a carrier having oneor more reagent deposits deposited thereon. In one embodiment, thereagent deposits are arranged in predetermined sets, with the setsprovided in containers. The system further includes pyroelectric filmpositioned adjacent the reagent deposits, and a reader operativelyassociated with the pyroelectric film (e.g., including a light emittingsource for illuminating the reagent deposit). Note that a set of reagentdeposits may consist of one reagent deposit. The system may also includea pump (or some other means of moving fluids and/or solids such as afan, pressure or vacuum generating device, etc.) for moving a sample ofthe local environment past or in the vicinity of the containercontaining the set, so as to initiate a reaction between the reagentdeposit and the target analyte to provide detection and indication ofthe target analyte. Among other elements, the preferred system may alsoinclude a filter operable with the pump and/or one or more alarms forindicating the presence of the target analyte. The filter may beoptionally mounted on a removable, modular subassembly such that it canbe interchanged to provide the optimum filter for the application.

The present invention is further directed to a method of employing thesystem and/or the system described above. Such an inventive methodallows for the detection and indication of one or more target analytessuch as a target gas. In another embodiment, the method allows for theindication of the amount or concentration of the target analyte inreal-time. Thus, in one aspect of the invention, the method provides forthe substantially simultaneous detection and indication of an amount ofthe target analyte in the local environment.

In a system for measuring or otherwise indicating the concentration ofat least one target analyte, a sensor carrier subsystem, according tothe invention, includes a transparent substrate having a first surface,a second surface disposed opposite of the first surface, and a reagentdeposit. The reagent deposit (e.g., a colorimetrically reactive reagent,fluorescent and luminescent clot) is supported on the first surface andis reactive when exposed to the target analyte. The reagent deposit isfurther characterized by a capacity to absorb electromagnetic energy(e.g., visible light, IR, near IR, UV light and microwave), wherein theabsorption capacity changes after the reagent deposit reacts uponexposure to the target analyte. An electromagnetic spectrum emittingsource or EM source (e.g. light emitting diode) is positioned proximalto the transparent substrate and closer to the second surface than tothe first surface. The EM source is operable to irradiate the reagentdeposit by way of a path directed through the transparent substrate. Apyroelectric transducer is positioned proximal to the reagent deposit todetect energy absorbed by the reagent deposit upon irradiation by the EMsource and to generate output signals indicative of the detected energy,such that the output signal is indicative of exposure to the targetanalyte. Thus the energy absorbed by the reagent deposit varies when thereagent deposit is exposed to the target analyte. By recognizing thischange in absorbed energy, a system can be realized that indicates thepresence of the target analyte.

Several variations of the carrier subsystem are possible and are withinthe scope of the invention. In one embodiment, the pyroelectrictransducer is positioned intermediate the transparent substrate and theEM source, such that the EM source is operable to irradiate the reagentdeposit by way of a path directed through the pyroelectric transducerand through the transparent substrate. Alternatively, the transparentsubstrate is positioned intermediate the transducer and the EM source.In another variation, the carrier subsystem includes a second EM sourcepositioned proximal the reagent deposit such that the first surface ispositioned intermediate the second surface and the second EM source. Ina further variation, the pyroelectric transducer (preferablytransparent) is positioned intermediate the transparent substrate andthe second EM source, such that the second EM source is operable toirradiate the reagent deposit by way of a path directed through thepyroelectric transducer.

In yet another variation, the reagent deposit is supported on thetransparent substrate such that the reagent deposit faces and is spacedapart from the pyroelectric transducer. The transparent substrate andthe pyroelectric transducer are spaced apart so as to provide a sampleenvironment flow path therebetween. In another variation, thetransparent substrate further includes a second reagent depositsupported on the second surface. The second reagent deposit may bedisposed on the second surface in generally vertical alignment with thefirst reagent deposit supported on the first surface. Moreover, a secondEM source may be positioned relative to the first EM source, such thatthe transparent substrate, the first and second reagent deposits, andthe pyroelectric transducer are positioned intermediate the first andsecond EM sources. Alternatively, a second EM source may be positionedproximal the first EM source, such that the pyroelectric transducer ispositioned intermediate the transparent substrate and the first andsecond EM sources.

In yet another variation, the carrier subsystem includes a secondsubstrate supporting a reagent deposit on a first surface and spacedapart from the pyroelectric transducer such that the second reagentdeposit faces the pyroelectric transducer. The EM source is operable toirradiate the second reagent deposit by way of a path directed throughthe transparent substrate and through the pyroelectric transducer.Alternatively, the second transparent substrate has a first surface anda second surface disposed opposite of the first surface, and a secondreagent deposit is supported on the first surface and spaced apart fromthe pyroelectric transducer. The second reagent deposit faces thepyroelectric transducer. Further, a second EM source is positionedproximal the second surface of the second transparent substrate and isoperable to irradiate the second reagent deposit by way of a pathdirected through the first and second surfaces of the second transparentsubstrate.

In another aspect of the invention, the carrier subsystem includes areflective surface positioned to redirect energy emitted by the EMsource to the reagent deposit. The reflective surface is positionedrelative to the EM source such that the transparent substrate, thereagent deposit, and the pyroelectric transducer are positionedintermediate the reflective surface and the EM source. Preferably, thereflective surface comprises a mirror, a wave-guide or the like.

The invention is also directed to a method of detecting the presence ofa target analyte in a sample environment utilizing a reagent depositreactive to exposure to the target analyte and further characterized bya capacity to absorb electromagnetic energy irradiated thereupon,wherein the absorption capacity changes after a reaction to exposure.The inventive method comprises several steps. In an initial step, atransparent substrate is provided having a first surface, a secondsurface disposed opposite the first surface, and a reagent depositsupported on the first surface. An electromagnetic energy emittingsource (EM source) is positioned relative to the transparent substratesuch that the second surface is positioned intermediate the firstsurface and the EM source. A pyroelectric transducer for detectingenergy absorbed by the reagent deposit is also positioned proximal thereagent deposit. The method further entails directing a sampleenvironment past the proximity of the reagent deposit, therebyinitiating a reaction between the reagent deposit and the targetanalyte. Furthermore, the EM source is operated to irradiate the reagentdeposit by way of a path directed through the transparent substrate. Thepyroelectric transducer is then utilized to detect the energy absorbedby the reagent deposit upon irradiation by the EM source and to generateoutput signals corresponding with a measure of the detected energy, suchthat the output signal corresponds with the degree of exposure. Thus,the amount of energy absorbed by the reagent deposit varies according tothe quantity of target analyte present in the sampled environment.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a simplified schematic representation of a gas detection andindication system and apparatus, according to the invention.

FIG. 2 is a simplified perspective view of a carrier suitable for usewith the system in FIG. 1.

FIG. 3A is a simplified perspective view of a second carrier suitablefor use with the system in FIG. 1.

FIG. 3B is an end view of the carrier at line 3B-3B in FIG. 3A.

FIG. 3C is a bottom view of the carrier in FIG. 3A.

FIG. 4 is a perspective view of a receiver and carrier according to theinvention.

FIG. 5 is a perspective view of a second embodiment of a receiver and acarrier according to the invention.

FIG. 6 is a simplified diagram of a detector tube according to theinvention.

FIG. 7A is a simplified diagram of the detector tube of FIG. 6 engagedwith a pump, according to the invention.

FIG. 7B is a simplified diagram of the detector pump of FIG. 6 engagedwith a second type of pump, according to the invention.

FIG. 8A is a simplified diagram of a third carrier suitable for use withthe system.

FIG. 8B is simplified plan view of the carrier in FIG. 8A.

FIG. 9 is a simplified diagram of a fourth carrier suitable for use withthe system.

FIG. 10 is a simplified diagram of a basic detection system according tothe basic system incorporating a pyroelectric film and an EMelectromagnetic spectrum emitting source, according to the invention.

FIG. 11 is a simplified diagram of an alternative detection systemincorporating a pyroelectric film and electromagnetic spectrum emittingsource, according to the invention.

FIG. 12 is a simplified diagram of yet another detection systemincorporating a pyroelectric film and electromagnetic spectrum emittingsource, according to the invention.

FIG. 13 is a simplified diagram of yet another detection systemincorporating a pyroelectric film and electromagnetic spectrum emittingsource, according to the invention.

FIG. 14 is a simplified diagram of yet another detection systemincorporating a pyroelectric film and electromagnetic spectrum emittingsource, according to the invention.

FIG. 15 is a simplified diagram of yet another detection systemincorporating a pyroelectric film and a plurality of electromagneticspectrum emitting sources, according to the invention.

FIG. 16 is a simplified diagram of yet another detection systemincorporating a pyroelectric film and a plurality of electromagneticspectrum emitting sources, according to the invention.

FIG. 17 is a simplified diagram of yet another detection systemincorporating a pyroelectric film and a plurality of electromagneticspectrum emitting sources, according to the invention.

FIG. 18 is a simplified diagram of yet another detection systemincorporating a pyroelectric film and a plurality of electromagneticspectrum emitting sources, according to the invention.

FIG. 19 is a simplified diagram of yet another detection systemincorporating a pyroelectric film and a plurality of electromagneticspectrum emitting sources, according to the invention.

FIG. 20 is a simplified diagram of a detection system incorporating apyroelectric film, an electromagnetic spectrum emitting source, and aplurality of reagents, according to the invention.

FIG. 21 is an alternative embodiment of a detection system incorporatinga pyroelectric film, an electromagnetic spectrum emitting source, and aplurality of reagents, according to the invention.

FIG. 22 is an alternative embodiment of a detection system incorporatinga pyroelectric film, a plurality of electromagnetic spectrum emittingsources, and a plurality of reagents, according to the invention.

FIG. 23 is an alternative embodiment of a detection system incorporatinga pyroelectric film, a plurality of electromagnetic spectrum emittingsources, and a plurality of reagents, according to the invention.

FIG. 24 is an alternative embodiment of a detection system incorporatinga pyroelectric film, a plurality of electromagnetic spectrum emittingsources, and a plurality of reagents, according to the invention.

FIG. 25 is an alternative embodiment of a detection system incorporatinga pyroelectric film, an electromagnetic spectrum emitting source, and aplurality of reagents, according to the invention.

FIG. 26 is an alternative embodiment of a detection system incorporatinga pyroelectric film, an electromagnetic spectrum emitting source, and aplurality of reagents, according to the invention.

FIG. 27 is a simplified diagram of a detection system incorporating apyroelectric film, a plurality of electromagnetic spectrum sources, anda plurality of reagents, according to the invention.

FIG. 28 is a simplified diagram of a detection system incorporating apyroelectric film, an electromagnetic spectrum emitting source, and aplurality of reagents, according to the invention.

FIG. 29 is a simplified diagram of an alternative embodiment of adetection system incorporating a pyroelectric film, an electromagneticspectrum emitting source, and a plurality of reagents, and including adeveloper and developing insert according to the invention.

FIG. 30 is a simplified diagram of an alternative embodiment of adetection system incorporating a pyroelectric film, a pluralityelectromagnetic spectrum emitting sources, and a plurality of reagents,according to the invention.

FIG. 31 is a simplified diagram of an alternative embodiment of adetection system incorporating a pyroelectric film, a pluralityelectromagnetic spectrum emitting sources, and a plurality of reagents,along with a developer and a developer insert according to theinvention.

FIG. 32 is a simplified diagram of a detection system incorporating apyroelectric film, an electromagnetic spectrum emitting source, and areflective surface, according to the invention.

FIG. 33 is a simplified diagram of an alternative embodiment of adetection system incorporating a pyroelectric film, an electromagneticspectrum emitting source, and a reflective surface, according to theinvention.

FIG. 34 is a simplified diagram of an alternative embodiment of adetection system incorporating a pyroelectric film, an electromagneticspectrum emitting source, and a reflective surface, according to theinvention.

FIG. 35 is a simplified diagram of an alternative embodiment of adetection system incorporating a pyroelectric film, an electromagneticspectrum emitting source, and a reflective surface along with adeveloper and a developer insert according to the invention.

FIG. 36 is a simplified diagram of an alternative embodiment of adetection system incorporating a pyroelectric film, an electromagneticspectrum emitting source, and a reflective surface, according to theinvention.

FIG. 37 is yet another alternative embodiment of a detection systemaccording to the invention, incorporating a pyroelectric film, anelectromagnetic spectrum emitting source, a container, a developer and adeveloper insert.

FIG. 38 is yet another alternative embodiment of a detection systemaccording to the invention, incorporating a pyroelectric film, anelectromagnetic spectrum emitting source, a container, a developer and adeveloper insert and a reflective surface.

FIG. 39 is yet another alternative embodiment of a detection systemaccording to the invention, incorporating a pyroelectric film, anelectromagnetic spectrum emitting source, a container, a developer and adeveloper insert.

FIG. 40 is yet another alternative embodiment of a detection systemaccording to the invention, incorporating a pyroelectric film, anelectromagnetic spectrum emitting source, a reflective surface, acontainer, a developer and a developer insert.

FIG. 41 is yet another alternative embodiment of a detection systemaccording to the invention, incorporating a pyroelectric film, anelectromagnetic spectrum emitting source, a reflective surface, adeveloper and a developer insert.

FIG. 42 is yet another alternative embodiment of a detection systemaccording to the invention, incorporating a pyroelectric film, aplurality electromagnetic spectrum emitting sources, a container, adeveloper and a developer insert.

FIG. 43 is yet another alternative embodiment of a detection systemaccording to the invention, incorporating a pyroelectric film, aplurality electromagnetic spectrum emitting sources, a container, adeveloper and a developer insert.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a schematic representation of a system 100 for detecting atarget substance or analyte in a local gaseous, fluid or liquidenvironment embodying various aspects of the present invention. In thepreferred embodiment, the system 100 is operable to indicate the amountor concentration of the target analyte that is detected. The inventionis also directed to a method of detecting such a target analyteemploying a combination of technologies and/or functions, most of whichare provided by the system 100 represented by FIG. 1.

As will become apparent, the present invention is adapted for variousapplications. For example, the detection system 100 has applications inthe general fluids detection market, particularly in the gas vapor,aerosol, and particulates detection market, as a portable or fielddeployable detector. In this market, one of the more frequently usedportable gas detectors comes in the form of badges covered with reagentsthat react colorimetrically with gases in the local environment. Thebadges are worn by the user and can provide a visual signal, in the formof a color change, when the reagent is exposed to the target gas. Atmost, these badges provide only an approximate measurement of the amountof gas in the local environment, relying on the user to compare orevaluate the degree of color change. The system(s) 100 depicted in theFigures provide a preferable replacement for these badges. Targetanalytes contemplated by the present invention include gases, vapors,liquids, solids, aerosols, and particulates as well as biotoxins,enzymes, antibodies, DNA, proteins, spores, viruses, bacteria, otherbiological materials and radiation. For example, in certain applicationsthe target analyte may be one or more of the following: merocyclic andtrichothecenes; including voridon E, Satratoxins F, Satrataxins G, andSatratoxins H, Trichoverris, verrucarol and verrucarin.

In one aspect of the invention, the inventive detection system 100employs or incorporates a core detection component provided by: anoptically detectable or colorimetric detection element, a pyrolectric orother thermoelectric transducer element operatively associated with thecolorimeteric detection element, and one or more carriers or substrates40 supporting or containing these two elements (see FIG. 1).Pyroelectric film (also called polyvinylidine fluoride (PVDF) or piezofilm) suitable for use with the present invention is described generallyin U.S. Pat. No. 5,622,868 (previously incorporated by reference above).One type of carrier 40 that is suitable for use with the inventivesystem is a cartridge-type carrier 40 as shown in FIGS. 2 and 3. Othertypes of carriers 40 also suitable for use with various embodiments ofthe invention are shown throughout in FIGS. 4-8. These other types andthe corresponding Figures are described separately below.

Returning now to the schematic representation of FIG. 1, the detectionsystem 100 includes a mechanism configured to receive an output from thetransducer element 40 and to convert the output into a readableindication of the amount or concentration of the target substancedetected. FIG. 1 illustrates one type of mechanism, a reader 60, that issuitable for use with the carrier 40 of the inventive detection system100.

The reader 60 includes an electromagnetic irradiation or illuminationsource in the form of an LED to irradiate or illuminate the reagent 32.The light is pulsed with a specific frequency preferably about 50 to 60hertz. The electrical signal produced by the heat shock or energyabsorbed or emitted by the pyroelectric film in the vicinity of thereagent deposit due to colorimetric, chemical, biochemical, physical,and/or molecular changes, is interpreted by an analog to digitalconverter, which is then processed by a microprocessor and displayed asa reading. The illumination or irradiation source may illuminate thereagent and pyroelectric film before they are exposed to a sampleenvironment to establish a baseline reading. This baseline reading maythen be compared to a later reading after the reagent and pyroelectricfilm have been exposed to a sample environment to recognize adifference. The magnitude of this difference may correspond to aquantity of target analyte present in the sample environment. Thismicroprocessor may have additional duties relating to pump control,temperature and humidity compensation of the PVDF reading, reading andwriting the memory chip stored in the PVDF film cartridge (as outlinedin this patent), control of alarm indicators such as visual, audible andvibration devices, and reading an optional bar code on a sensor and/orfilter module. In any case, a reader suitable for use with the presentinvention is one that incorporates many of the basic mechanisms asdescribed in U.S. Pat. No. 5,622,868.

FIG. 1 further illustrates the use of a pump 10 in conjunction with aflow sensor 14 and flow regulator 12 for drawing and then controlling aflow of the local gaseous environment into or across the carrier 40. Aflow filter 16 may be recommended as well in certain demandingenvironments. As further explained below, the use of a pump 10 in thedetection system 100 allows for measurements which are exceedingly moreaccurate and consistent than currently provided by the above-mentionedbadges and other known detection systems. The pump 10 also provides facevelocity at the surface of the analyte to allow a sufficient amount ofanalyte to expose and react with a reagent. Applicants have also foundthat pump 10 in this way accelerates the responsive time and sensitivityof the detection system 100. The use of a pump also allows forincorporation of filters, including high resistance filters to removeinterferants and poison contaminants from the sample environment, and/orto facilitate separation and specificity of analyte that will not,otherwise, diffuse through the filter with the fluid flow.

Depending on the requirements of a particular application, the detectionsystem 100 may include a number of sensors, alarms and otherinstrumentation, each of which is operable with or linked to a controlmechanism 22, as shown in FIG. 1. For example, the detection system mayinclude a digital display 26 for visually indicating the concentrationof the target substance, and one or more visual alarms 28 (e.g.,flashing red LED), audible alarms 30, and vibration alarm 31. The alarmsmay be configured to activate when certain threshold levels of thetarget substance are detected. The detection system 100 may also includea temperature sensor 18 and a humidity sensor 20.

In several embodiments, including the embodiment depicted in FIG. 4, aportable, self-contained housing 62 is provided to house or frame thepiezofilm reader 60 and the various sensors, alarms, pump-relatedcomponents, and other accessories. This housing 62 also includes amicroprocessor or equivalent means for performing or controlling variousfunctions, including conversion of pyroelectric film output to areadable digital indication. This self-contained housing 62 may bereferred as to as the carrier receiving device or simply, the reader 62.In several embodiments, engagement between the carrier 40 and the reader62 also initiates sampling of the local environment and testing for thetarget substance in that sample. Also, in several embodiments, thereader 62 is adapted to be field deployable, portable testing equipment.

Referring now to FIGS. 2-5, the cartridge-type carriers 40 depictedtherein are separate from the reader 62 but are engageable therewithduring a testing operation (and detachable therefrom for another testingoperation). FIG. 4 depicts the carrier 40 in engagement with a flip-toptype reader 62. FIG. 5 depicts another cartridge-type carrier beingdisengaged from a second type of reader 162.

The carrier 40 preferably employs a colorimetric detectable element inthe form of reagents 32 that selectively react with chemicals, or targetsubstances, in the gaseous or other fluids environment. The reagents arealso characterized by the amount of electromagnetic radiation they canabsorb or emit, which translates to microscopic heat shock or energygenerated or absorbed within the reagent. Thus, the reagent may beirradiated with an LED or other light source or microwave orelectromagnetic enery source to cause heat to be generated within thereagent. In turn, a pyroelectric film transducer is employed to measurethe temperature change across the reagent, which directly corresponds toa voltage generated by the transducer. Upon exposure to the targetsubstance, the reagent deposit undergoes a change (chemical,biochemical, physical and/or molecular), and as a result of the change,the reagent deposit's capacity to absorb or emit energy also changes.Thus, the reagent deposit may be irradiated before and after a testingoperation and the corresponding change and the difference in the heat orother forms of energy generated in the reagent calculated. Thecalculated voltage change is then translated into a correspondingconcentration of the measured analyte by the reader 62.

In the embodiment illustrated, reagents 32 preferably undergo acolorimetric change upon detection of a target analyte. As a result, thereagent's capacity to absorb light changes. Thus, the reagent depositmay be illuminated before or after a testing operation and then thedifference in the heat generated due to illumination after eachoperation (absorption capacity) is calculated or the reagent deposit maybe irradiated after the exposure to the analyte and compared to standardfor the output of the reagent deposit when irradiated in absence of theanalyte. In this preferred system, the pyroelectric film will generate avoltage between electrodes. The difference in the voltages generated orthe difference in voltage generated and the standard when no analytepresent, will correspond to a concentration of the target analytemeasured. In one aspect of the invention, the system 100 provides forthe pyroelectric film transducer/reagent to be re-set or baselined. Thismeans that, after a detection of the target substance and correspondingcolor change in the reagent, the reader stores voltage measured afterthe reagent is illuminated by a given LED. In this way, if a subsequentLED illumination does not result in a larger amount of heat beingdetected (i.e., because of no further colorimetric change in thereagent), the output signal may be recognized as the same as thatreceived in the previous illumination, and thus the reader will notindicate erroneously that the target substance has again been detected.On the other hand, if additional exposure caused the reagent to furtherreact colorimetrically, then the voltage measured would be different andthe difference in voltage can be used to indicate the concentrationdetected. The output change is directly proportional or inverselyproportional to the amount of the change on the reagent deposits uponexposure to the target analyte. Direct and inverse proportionalitydepend on the nature of the reagent deposits and the target analyte.

The above-described resetting or baseline method is just one example ofa suitable method that allows the reagent to be repeatedly illuminatedand exposed a plurality of times. In each case, the system 100effectively stores in a memory the amount of heat (or correspondingvoltage) that a reagent absorbs in response to an LED illumination. Thisallows the reagent to be reused, and be used longer in the field. Thisalso allows the system to discriminate between different degrees ofexposures. It is important to note, however, that the resetting orbaselining described above requires the reagent to be non-reversible(does not revert back to its original color). The non-reversible reagentwill have a maximum value of exposure at which point the reagent istotally consumed or saturated. At this point of maximum exposure, thereagent cannot be used to read any further exposures of analyte. Themaximum total change of the reagent will be stored as a data valuewithin either the memory chip on the reagent carrier or other memorysuch as the internal memory in the microprocessor. In the case ofreversible reagents, the reagent will revert back to the original statusin the absence of the target analyte. However, even the reversiblereagent will have a maximum exposure point at which the reagent may bedamaged and an expiration date that would be stored within the memory asdescribed above.

In yet another aspect of the inventive testing method, a non-reversiblereagent/pyroelectric film is used in combination with a continuouslyrunning pump. The pump is operated to continuously sample the localfluids environment while the LEDs of the reader is activated toilluminate intermittently. Whenever a target substance is detected,causing a colorimetric reaction and subsequent reading of theconcentration detected, the reagent/pyroelectric film is reset orbaselined. In this manner, the system 100 may be used for continuousmonitoring in the field and multiple exposures.

FIG. 2 provides the basic structure of a carrier 40 for use with thesystem 100 according to the invention. The carrier 40 of FIG. 2 includesa plurality of colorimetrically reactive reagent deposits 32 depositedthereon. Different types of reagent deposits 32 may be selected suchthat one testing operation can detect a corresponding plurality oftarget substances. The reagent deposits 32 are preferably arranged inpredetermined sets 32 a. In one preferred embodiment, the system 100includes a series of distinct reagent deposits 32 provided in the sameset 32 a, such that several target substances may be tested at the sametime. Alternatively, a predetermined set 32 a may consist of one reagentdeposit (see e.g., FIG. 3 a).

The carrier 40 further includes a pyroelectric film transducer 42 onwhich the reagent deposits 32 are deposited. The reagent deposits 32 maybe deposited directly on the pyroelectric film transducer 42 using anink jet printer or a screen print system. The pyroelectric filmtransducer 42 has a top surface 36 and a bottom surface 38. Inembodiment of FIG. 2, the top and bottom surfaces 36, 38 provide theelectrodes by which an electrical signal may be outputted from thecarrier 40.

FIGS. 3 a-3 c depict a variation of a carrier 40 according to theinvention. To facilitate description, the cartridge 40 of FIG. 3 isshown with only one reagent deposit 32. The reagent deposit 32 iscontained or housed within an initially sealed tunnel 34, as best shownin end view of FIG. 3 b. The tunnel 34 is essentially an elongatedconduit extending the length of the cartridge 40 providing for fluidcommunication between the pump 10 and a local fluid environment.Preferably, the tunnel 34 also contains a filter 68 shown in FIG. 4. Thetunnel 34 further includes an inlet end 34 a and an outlet end 34 b,which provides a conduit for passage of a sample of the local fluidenvironment. The inlet and outlet ends may be sealed by a plastic filmor the like. As further described below, upon engagement of thecartridge 40 with the reader 62, the sealed inlet end 34 a and outletends 34 b are simultaneously punctured, thereby creating the fluidconduit and allowing for exposure of the reagent 32 to the localenvironment.

Referring to the end view of FIG. 3 b, the pyroelectric film transducer42 is provided as a mat situated along the bottom portion of the tunnel34, thereby providing a bed or support for the reagent 32. In onevariation of the cartridge 40, the cartridge 40 is made of glass suchthat the bottom surface on top surface of the tunnel is sealed by aglass surface. In further embodiments, the top end may be sealed by aplastic film.

Now referring to the bottom view of FIG. 3 c as well, the carrier orcartridge 40 also includes an embedded memory chip 52 with leads or pinsmateable with the reader 62. The memory chip 52 may be used tocommunicate the characteristics of the reagent dot 32 as well as thetesting protocol or procedure for the target substance. The bottom viewof FIG. 3 c also shows lead lines 54 and connectors extending from thepyroelectric film. The connectors are situated so as to be mateable withcorresponding connections on the piezoreader 60. Further, the cartridge40 is also provided with a key/alignment hole or pin 56 for aligning thecartridge 40 with a corresponding hole or pin of the reader 62.

FIG. 4 shows the cartridge of FIG. 3 engaged within a receivingcompartment or bay 66 of the flip top reading device 60. When properlysituated in the compartment, as provided by aligning the key alignmenthole with the corresponding key alignment pin of the reader, theconnectors 54 for the pyroelectric film 42 and those for the memory chip52 align with and connect with corresponding connections on thepiezoreader 60. Moreover, the inlet and outlet ends of the tunnel 34 ofthe cartridge 40 align with corresponding conduits integrated with thereader 62. A tab device provided on the compartment may be positioned soas to puncture the inlet and outlet ends 34 a, 34 b. In this way,operation of the pump 10 draws a sampling of the local gaseous or fluidenvironment through the tunnel 34, thereby exposing the reagent 32 andinitiating a colorimetric change therein. FIG. 4 also illustrates theuse of a pump 10 having a pumping conduit 10 a connecting the cartridgewith the pump 10, and also with the sampling inlet 10 b and outlet 10 c.

The display 26, shown in FIG. 4 is a standard LCD display, and may bealpha-numeric or graphical depending on what information is necessary todisplay. The display 26 provides the user with a numeric indication ofthe measurement of the concentration of the target substance (eitherdirect immediate exposure or long term dosimeter readings). The display26 may also display text and graphics of alarms, menus for devicesettings including: alarm points; time; date, data-logging; analytename; sensor name; filter name; parts numbers; software names andversion; temperature; humidity; altitude; pressure; sampling time;operating instructions, sampling volume, serial number, lot number,expiration date, interferences, unit of measure, over range, minimumdetectable limit, accuracy, sample flow, flow rate, number of exposures,location, designation, test operator identification, accessories names,developer names, reagent saturation, range, environment operationconditions and corrections factors, or any other information, data orthe like necessary for operating the device.

The pump 10 may be a fan, air pump, or other device that is capable ofmoving a sample of the local environment. The pump may be located oneither the intake air path before the reagent or located in the exitingair path. The pump 10 may be operated continuously or intermittently, ormay be turned on for a specific amount of time for purposes of obtaininga reading or to minimize power consumption or until a specific volume ofthe local environment has been sampled. Alternatively, the pump may beknown to operate at a specific flow rate to increase, decrease orotherwise vary the sample through conduit 34.

In the preferred embodiment of the invention, the pump 10 is used with aflow regulator 12. If the invention did not employ a flow regulator 12,the pump would be used as an uncontrolled fluid source that wouldindicate the presence of a fluid, but the measurement of the amount ofthe target fluid would not be as accurate as a measurement taken with aflow regulator 12. The flow regulator 12 can either use feedback fromthe motor or from the flow sensor 14. A preferred method is to controlelectrical power to the pump device with a feedback from the flowsensor. Such regulation may consist of controlling the pump speed and/orthe on and off time of the pump in either a pulsed fashion or on for aspecific time period. The flow regulator consists of an electric circuitthat interfaces with the flow sensor 14 (or motor feedback) and providespower to the motor directly.

The inventors have discovered that the use of a pump 10 in combinationwith pyroelectric (and other) technology provides certain benefits. Forexample, the use of a pump speeds up the reaction time of the reagentand allows for a virtually instantaneous measurement of the level of thetarget substance in the local environment.

Furthermore, precise control of the pump, as in the present invention,provides measurements exceedingly more accurate than is achievable withprior art systems and methods. This achievement by the inventors stemsfrom the understanding that the chemical, biochemical, biological,physical and/or molecular reaction of the reagent deposit isproportionally relevant to the amount of fluid, air or gas that iscontacted with the reagent deposit surface. With prior art colorimetricreactions, the fluid, air or gas is contacted with the reagent throughsimple diffusion—which has to be timed in order to provide anacceptable, accurate measurement. In the present inventive system andmethod, the flow rate of the pump can be measured and/or controlled, aswell as the pumping duration, and thus, the amount of fluid, air or gascontact with the reagent can also be measured and/or controlled. As aresult, a high level of accuracy in measurements can be achieved andrepeated. Moreover, use of the pump to initiate or encourage contactprovides more precise measurements than the use of simple diffusionbecause the diffusion rate may be affected and varied by externalconditions, including wind. The flow of the pump will either becontrolled by an orifice, mechanical control, analog electronic feedbackor digital electronic feedback. The method of measurement of motor speedcould be accomplished by voltage, optical to electrical, electricaltiming signal or measurement of the inlet flow versus outlet flow of thepump.

Alternatively, a measurement device may be used to measure the amount ofsample delivered by the pump. If the pump 10 operates at a known flowrate, the measurement device could comprise of a timer which may beinternal or external to the microprocessor to time the length ofoperation of the pump and a converter to convert the flow rate and thepump operation time to a volume of sample delivered. The flow sensor 14may be provided as the optional measuring device to provide feedback tothe flow regulator 12. The preferred method of flow sensing employs adifferential pressure sensor. A wide range of sensors, includingelectromechanical sensors, hot wire sensors, optical sensors and manyothers can be used.

Further, the reader 62 preferably includes a circuit board or othersupport 70, which includes the reader 60, as well as the controlmechanism 22. When the cartridge 40 is received in the bay 66, it issituated over the board 70, and such that LED's provided on the boardadvantageously align with the reagents 32. In further embodiments,multiple LED's of various wavelength maxima (e.g., colors) may beemployed in combination with a light pipe or fiber optic conduit forselectively irradiating the reagent with a variety of light sources. Theboard 70 also includes contacts for the memory chip 52 such that reagentinformation and testing requirements may be communicated to the reader62.

FIG. 5 depicts yet another reader 162 and carrier 140 combinations,according to the invention. The carrier 140 is shown being disengaged ordetached from the receiving bay 166 of the reader 162. The carrier 140includes one or more containers 110, each containing a set of reagentdeposits 132. Preferably, the container 110 is a channel that isparticularly adapted to fluidly communicating the local environment withthe selected set of reagent deposits 132.

In one embodiment, the carrier 140 may be fed into the reader 162 by anelectric motor. In another embodiment, the carrier 140 may be fedthrough operation of some type of ratchet or manually fed by hand. Thecarrier 140 could be made of a firm, durable plastic and may contain abarcode, magnetic stripe or embedded memory chip or bar code to identifythe specific carrier 40 and the target analytes, the ranges it iscapable of detecting, and other information.

The system further includes a means for selecting or designating apredetermined set of reagent deposits 132 for exposure to the samplecontaining the target substance. In this manner, the user selects aspecific reagent deposit to test for a target substance. Upon engagementof the carrier 140 with the reader 162, the selecting means penetratesthe container 110 containing one set of reagent deposits, therebyexposing the selected reagent deposits to the local environment, asfurther discussed below.

The system 100 embodies a reagent deposit 132, which due to its limitedquantity is easily and quickly reacted upon exposure to air andhumidity, causing a short “shelf life.” In another embodiment, eachcontainer 110 containing a set of reagent deposits 132 is covered by ashield 130, shown in FIG. 5 as a tunnel, to shield the reagent deposits132 from the local environment until the carrier 140 is engaged with thereader 162. Upon engagement of the carrier 140 with the reader 60, theshield of the selected set of reagent deposits 132 is penetrated orcompromised, allowing exposure of the selected set of reagent deposits132 to the local environment containing the target substance. The tunnelis preferably made of glass, but could also be made of another rigidmaterial such as Mylar or polyvinyl chloride. The ends of the tunnel arepreferably covered with film that may be compromised or punctured toexpose the container 110. Alternatively, the shield 130 could consist ofa film covering each container 110. In one aspect of the invention, theshields (either in the form of a film covering or a tunnel) allow formultiple testing procedures using the same carrier 140. During a testingoperation only the selected set of reagent deposits 132 are exposed,leaving the remaining sets of reagent deposits unexposed beneath theshield. The shield-compromiser preferably consists of a sharp implementto puncture the film-covered ends of the tunnel or the film.

In another embodiment of the invention, a filter is used to filter outinterferences from the local environment containing the target substancebefore the local environment comes in contact with the selected set ofreagent deposits. The filter may comprise a variety of materials andcoatings to specifically filter interferences (through membranes thatrestrict particle size, chemicals that react with, remove, or change achemical compound into another chemical that will not interfere with thetarget analyte) from the selected set of reagent deposits. Filtersremove undesirable substances through adsorption, absorption, chemicalreaction, biochemical reaction, biological, and/or molecularinteraction. The filters may have the shape of porous numbers, liquid orsolid encapsulated or porous solid supports. The filters may, in thealternative, be in the form of a chromatography column with filteringmedia coated on the inside walls. The sample environment, including theundesirable particulates, is passed through the column along the coatedwalls, and fractionally separates. Because of the temporary nature ofchromatographic columns, this type of filter is preferably for use withportable type systems. This type of filter has the advantage oftemporarily holding back the interfering substance during measurement ofthe primary target chemical, but then allows for measurement of theinterfering substance when heat is applied (and release of theinterfering substance). Specific filters could include a hydrophobicfilter to remove humidity, a filter to screen out toluene and xylenefrom benzene and air, a filter to remove chlorine gas from a mixture ofchlorine dioxide and air, a filter to absorb or adsorb water vapor andmany others. The filters may be reversible, nonreversible, reusable andnonreusable.

These filters may be used individually or in combination as needed tofilter interferences from the selected set of reagent deposits 32.Further uses of such filters will be apparent to one skilled in the artupon review of the present disclosure.

Like the pump, the filters can be engageable with the container 110containing the selected set of reagent deposits. The filters couldoptionally be stamped with a bar code such that they may be recognizedby the reader 162 with a barcode reading device. This would allow thereader 162 to compensate, or report to the user the use of the filter orthe lack of presence of the filter. Furthermore, the filters couldoptionally be constructed in such a manner that the filter itself wouldcontain or be made of a colorimetric substance that would cause a colorchange of the filter material showing that the material is beingconsumed or that it has been fully consumed or the rate at which it isbeing consumed.

As previously mentioned, the cartridge is mateable with and thendetachable from the reading apparatus. When keyably engaged with thereading apparatus, the air channel, flow path cartridge channel, andoutlet are fluidly aligned so as to allow for the passage of pumpedfluid or air therethrough. Alternatively, the reading apparatus may beequipped with a key or piercing mechanism for piercing film sealablyapplied to the ends of the cartridge channel. Thus, upon proper receiptof the cartridge in the cartridge bay, the reagent deposits may beexposed with fluid sample from the local environment. Accordingly,detection and indication of the target fluid can occur immediately.

One way for the unit to “open” or “pierce” the cartridge is for the unitto contain two hollow pins which are sufficiently long to puncture thebottom of the cartridge at each end providing fluid path though thepuncture pins themselves. Due to the possible manufacturing difficultyof puncturing the cartridge, one preferred method of cartridgeconstruction would entail a cartridge as shown in FIGS. 3-5. This wouldbe the composite of two plastic plates that, when joined together form a“credit card” shaped plastic device with a hollow interior forming atunnel or channel through the middle of the device. Prior to assembly ofthe opposing halves of the cartridge, the embedded pieces would beplaced inside the device, then both pieces would be assembled and sealedpossibly with a heat seal, sonic weld, a glue or the like.

FIG. 6 depicts yet another embodiment of the invention. In thisembodiment, a detector tube 206 is employed to support the carrier 40during storage and testing. The detector tube 206 is a hermeticallysealed glass tube, structurally similar to those commercially availablein the industry. The detector tube has a breakable inlet end 208 a and abreakable outlet end 208 b. The carrier of FIG. 6 includes threereagents spots 232 supported on a pyroelectric film transducer 240. Thecarrier further includes two wire lead lines 212 that are directedthrough the walls of the glass tube, thereby providing two electricalconnections for use with a reader. The detector tube 206 may also housea layer of LED(S) positioned adjacent or beneath the carrier so as to beoperable for irradiation of the reagents. In the alternative, the LEDlayer may be positioned outside of the detector tube 206 andincorporated with the reader.

FIGS. 7A and 7B depict the detector tube 206 operated with a bellowspump 210 a and a manual pump 210 b. Either pump may be used incombination with the detector tube 206 to conduct a field-testingoperation. In particular, the detector tube ends are broken and insertedor engaged with the pump, thereby drawing a sampling of the environmentthrough the detector tube and past the reagent. Thus, if the reagent isexposed to the target substance, a colorimetric change occurs. Thedetector tube is then disengaged from the pump and engaged with theappropriate reader such that the connections 212 mate with correspondingconnections in the reader. Upon engagement with the reader, one or moreLEDS on the reader may be operated to irradiate the reagent.

FIGS. 8A and 8B depict yet another variation of a carrier for use withthe system according to the invention. In particular, FIG. 8 depicts theuse of a reel-to-reel tape mechanism 306 for sealingly storing anddispensing individual carriers 340. As shown in FIG. 8B, the reel tapemay be segregated into distinct sections, including a section comprisinga carrier 340. The carrier will include pyroelectric film transducer 340and one or more reagent deposits 332 thereon. Conveniently, the tapeacts to seal the reagent 332 before the reagent 332 is exposed duringunwinding, thereby eliminating the need for a sealed container ortunnel. Accordingly, one benefit of the embodiment of FIGS. 8A, 8B isthat it allows for “long term” measurement, while preserving the life ofthe unused reagents.

The roll of tape may include various combinations of reagents or onlyone type of reagent. Further, the reel-to-reel mechanism may be mountedor housed integrally with a reading device. In the alternative, thereel-to-reel mechanism may be integrated with a fixed testing mechanismrather than a field deployable portable gas detector.

FIG. 9 depicts yet another variation of a carrier for use with thesystem according to the invention. The carrier of FIG. 9 is a disk typecarrier 440 preferably holding a plurality of reagent deposits 432. Thereagent deposits 432, as before, will be deposited on and supported by amat of pyroelectric film 442. The pyroelectric film 442 may beindividual mats or a continuous, circular sheet of film, as shown inFIG. 9. The bay 66 of reader 62 may be modified to accommodate either ofcarriers 340 or 440 for use.

FIG. 9 also illustrates a reagent deposit sealingly situated in a tunnel434. The tunnel 434 includes fluid communication inlets (not shown) andoutlets 436, which are penetrated and unsealed upon engagement of thedisk carrier 440 with the appropriate reader. For example, in FIG. 9,only one reagent deposit remains unsealed, but is positionally engagedwith the reader so as to be in alignment with the pumping means providedby the reader. When aligned and in operation, the pump may be operatedto draw air from the periphery of the tunnel and past the reagent,towards the center of the disk carrier 440. Upon conclusion of a testingoperation, the disk carrier 440 may be rotated so as to align yetanother reagent deposit for a subsequent operation. As before, thetunnel 434 may be covered by glass or film, with the ends preferablycovered by a puncturable or penetrable film sheet.

FIG. 10 depicts an alternative arrangement for the system of detecting atarget analyte utilizing pyroelectric technology, according to theinvention. The system 1000 includes at least one reagent deposit 1001supported on a transparent substrate 1002. The transparent substrate1002 may be glass or plastic such as polyester, polypropylene or PVC.The reagent 1001 is formulated, coated, impregnated and/or deposited onthe substrate 1002 under reduced pressure or vacuum so as to preventbubbles from being retained within the reagent 1001. The substrate 1002is positioned adjacent a piezoelectric or pyroelectric film 1003 havinga top metallic conductive film surface 1004 a and a bottom conductivefilm surface 1004 b. The piezoelectric or pyroelectric film may becomprised of polivinylidine fluoride (PVDF) material. The top conductivefilm surface 1004 a is spaced directly apart from the transparentsubstrate 1002 as shown in FIG. 1.

The system 1000 further includes an electromagnetic spectrum emittingsource 1005 (EM source), e.g., LED, positioned, at least in thisembodiment, below the pyroelectric film 1003. As described previously,the pyroelectric film 1003 is adapted to detect energy changes withinthe reagent 1001 (i.e., as a result of exposure to the target analyte).In the embodiment of FIG. 10, the flow or passage of the sampleenvironment, 1008 (hereinafter “sample fluid flow”), is directed fromabove the substrate 1002 onto the reagent 1001. The EM source 1005 isoperable to direct light, for example, through the pyroelectric film1003 and the transparent substrate 1002. The pyroelectric film 1003 isfurther provided with conducting electrodes or terminals 1007 positionedpreferably in conductive connection with the metallic conductive filmsurfaces 1004 a, 1004 b, and at one the end of the pyroelectric film1003. As illustrated in FIG. 1, the pyroelectric film 1003 communicates,via the conductive terminals 1007, a set of generated electricalimpulses 1006 that corresponds to the measurement of the energy changewithin the reagent 1001. If a target analyte is present in sample 1008,the resultant change produced in reagent 1001 is measured by a change inimpulses 1006. This change may then be used to trigger an alarmindicating a specific amount of the target analyte.

In FIG. 11, the reagent deposit 1001 is supported on the transparentsubstrate 1002, but the transparent substrate 1002 is positioned belowthe pyroelectric film 1003. Moreover, the EM source 1005 is positionedbelow the transparent substrate 1002, and is operable to direct energytowards and through the transparent substrate 1002. In this particulararrangement, the direction of fluid flow 1008 is provided in between thetransparent substrate 1002 and the pyroelectric film 1003. Furthermore,the pyroelectric film 1003 is positioned above and spaced apart from thereagent deposit 1001 to detect energy absorbed by the reagent 1001.

In the alternative arrangement of FIG. 12, the reagent deposit 1001 isdeposited directly on an electrically conductive film 1009. Theconductive film 1009 may be thin metal film or metallized plastic. Inturn, the electrically conductive film 1009 is supported directly on thepyroelectric film 1003, and more specifically, directly on theconductive film surface 1004 a. Thus, the pyroelectric film 1003 candetect energy changes in the reagent deposit 1001 by way of theelectrically conductive film 1009 by mere physical contact.

In the arrangement illustrated in FIG. 13, the reagent 1001 is depositedon a thermally conductive paste 1012 that is supported on thepyroelectric film 1003. Further, the thermally conductive paste 1012 issupported directly on the pyroelectric film 1003, and more particularly,on the top conductive film surface 1004 a. As in FIG. 12, the EM source1005 is positioned above the reagent deposit 1001. A suitable thermallyconductive paste 1012 is a conductive polymeric or inorganic metallizedpaste. Operation of the illustrated system further requires the use of apipette, dropper and/or applicator 1011 to communicate additionalreagent and/or developer 1010 onto the reagent deposit 1001. This isneeded as some reagents deposits require addition of other reagent(s)before and/or after sampling to activate or to react with the reagentsdeposits and/or the fluid analyte(s) to enable the desired detectionresponse upon exposure to the fluid analyte(s).

Now turning to FIG. 14, an alternative arrangement is shown wherein thereagent deposit 1001 is positioned on to a bottom side of thetransparent substrate 1002. As further shown, the pyroelectric film 1003is positioned below and spaced apart from the transparent substrate1002. In this way, the sample fluid flow direction 1008 is moved betweenthe transparent substrate 1002 upon which reagent deposit 1001 isdeposited and the pyroelectric film 1003. Moreover, the EM source 1005is preferably positioned above the transparent substrate 1002, so as todirect energy towards and through the transparent substrate 1002 andthen to reagent deposit 1001.

FIGS. 15-19 illustrate yet further alternative arrangements for thesystem 1000 according to the invention. In each of these arrangements,the system 1000 employs at least two EM sources 1005 to direct energytowards the reagent deposit 1001. In the arrangement shown in FIG. 15,an EM source 1005 is positioned both above and below the pyroelectricfilm 1003. The use of a pair of EM sources 1005 provides forintensification of the electromagnetic spectrum that is irradiated onthe reagent deposit 1001. As a result, the sensitivity of the system isincreased to yield more precise detection of target analytes.

In FIG. 15, the reagent deposit 1001 is deposited on a transparentsubstrate 1002, which is positioned above and spaced apart frompyroelectric film 1003. The pyroelectric film 1003 further includes atop metallic conductive surface 1004 a and a bottom metallic conductivesurface 1004 b. The conductive surfaces 1004 connect to a pair ofelectrodes 1007, which, during operation, generates electric signals1006 that correspond to the measurement of the energy (i.e., energychange) retained or embodied in reagent deposit 1001.

In the alternative arrangement of FIG. 16, the reagent deposit 1001 issupported on transparent substrate 1002, which is positioned below thepyroelectric film 1003. In this way, the reagent deposit 1001 is betweenthe two film surfaces 1003, 1002, and in the direction of flow 1008therebetween. Again, as in FIG. 15, an EM source 1005 is positionedabove and below the reagent deposit 1001, and more specifically, abovethe pyroelectric film 1003 and below the transparent substrate 1002. Inthis way, the intensity of the EM energy directed upon reagent deposit1001 is intensified, thereby increasing the sensitivity of the inventivesystem.

Referring now to the alternative arrangement illustrated in FIG. 17, thereagent deposit 1001 is supported directly on an electric conductivefilm 1009. Further, the electrically conductive film 1009 is supporteddirectly on the pyroelectric film 1003. As with the previously describedembodiments, the pyroelectric film 1003 has a top metallic conductivesurface 1004 a and a bottom metallic conductive surface 1004 b. Again,an EM source 1005 is positioned both above and below the reagentdeposit, thereby intensifying the EM energy irradiated upon the reagentdeposit 1001. In this way the sensitivity of the inventive system 1000is also increased.

In the system 1000 of FIG. 18, the reagent deposit 1001 is deposited ona thermally conductive paste 1012, which is supported on thepyroelectric film 1003. The EM sources 1005 are positioned above andbelow the reagent. The embodiment of FIG. 18 illustrates the use of anadditional reagent and/or plurality of reagents and/or developer 1010which are to be added prior to and/or after a sampling operation by wayof applicator 011.

In the system 1000 of FIG. 19, the transparent substrate 1002 supports areagent deposit 1001 on a bottom surface, and the transparent substrate1002 is spaced above and apart from pyroelectric film 1003. Then, an EMsource 1005 is positioned both above the transparent substrate 1002 andbelow the pyroelectric film 1003. In this way, the sample flow 1008 isdirected between the transparent substrate 1002 and the pyroelectricfilm 1003.

FIGS. 20-23 illustrate alternative arrangements of the inventive system1000, wherein a plurality of reagent deposits 1001 are employed.Further, FIGS. 24-31 illustrate alternative arrangements wherein aplurality of EM sources 1005 is employed in conjunction with theplurality of reagent deposits 1001. In FIG. 20, a reagent deposit 1001is deposited on both top and bottom surfaces of transparent substrate1002, and at locations in generally vertical alignment (i.e., theposition of the reagent deposits 1001 correspond to one another onopposite sides of the substrate 1002). This system 1000 provides for asample flow 1008 above the transparent substrate 1002, and in betweenthe transparent substrate 1002 and the pyroelectric film 1003. Thisarrangement also provides two locations wherein reactions between thereagent 1001 and the target analyte can occur. In this particularembodiment, the EM source 1005 is positioned below both the transparentsubstrate 1002 and on the other side of and below the pyroelectric film1003. At this position, the EM source 1005 can direct EM energy throughthe pyroelectric film 1003, then through a reagent deposit 1001 and thetransparent substrate 1002, in order to reach the second reagent deposit1001.

In the arrangement depicted in the system 1000 of FIG. 21, the reagentdeposits 1001 are again provided on opposite sides (above and below) thetransparent substrate 1002. In this particular embodiment, the reagentdeposits 1001 are not positioned, however, at locations that arevertically aligned on opposite sides of the transparent substrate 1002(as in FIG. 20). In this way, the EM source 1005 directs EM energythrough the pyroelectric film 1003 and through the transparent substrate1002, in order to reach the top reagent deposit 1001 (i.e., bypassingthe bottom reagent deposit 1001).

Now referring to FIG. 22, the arrangement illustrated therein utilizes apair of reagent deposits 1001 located on opposite sides of thetransparent substrate 1002. The reagent deposits 1001 are verticallyaligned. Further, the arrangement includes a pyroelectric film 1003positioned below and spaced apart from the transparent substrate 1002.In this arrangement, the system 1000 further includes a pair of EMsources 1005 positioned above the transparent substrate 1002 and belowthe pyroelectric film 1003. The bottom EM source 1005 is operable todirect EM energy through the pyroelectric film 1003 and to the bottomreagent deposit 1001. The top electrode 1005 is positioned above the topreagent deposit 1001 to direct energy directly into the reagent deposit1001.

The system 1000 illustrated in FIG. 23 provides yet another variation ofthe invention. In this particular arrangement, reagent deposits 1001 arepositioned above and below the transparent substrate 1002, but are notvertically aligned. In the operation of the system, EM energy isdirected from below the pyroelectric film 1003, through the pyroelectricfilm, and towards the transparent substrate 1002. In this particulararrangement, a pair of EM sources 1005 are both positioned below thepyroelectric film 1003, each of which is in general vertical alignmentwith one of the reagent deposits 1001. Thus, in respect to thearrangement depicted in FIG. 23, the left most EM source 1005 directsenergy through the pyroelectric 1003, through the transparent substrate1002, in order to reach the top reagent deposit 1001.

The system 1000 illustrated in FIG. 24 is a further variation of thesystem 1000 in FIG. 23. In this particular arrangement, a second pair ofEM sources 1005 are positioned above the transparent substrate 1002.This system 1000 provides EM sources 1005 that can direct EM energy toeach of the reagent deposits 1001 from both below and above thetransparent substrate 1002.

FIGS. 25 and 26 each illustrates yet another alternative arrangementaccording to the invention, wherein two transparent substrates 1002 areemployed. Specifically, a transparent substrate 1002, having a reagentdeposit 1001 supported thereon, is spaced apart above and below thepyroelectric film 1003. In this way, two sample fluid flows 1008 arecreated between the pyroelectric film 1003 and each of the transparentsubstrate 1002. In these arrangements, the top transparent substrate1002 supports the reagent deposit 1001 on a bottom surface and is spacedapart from the pyroelectric film 1003. Further, an EM source 1005 ispositioned below the bottom transparent substrate 1002. The EM source1005 is operable to direct EM energy through the bottom transparentsubstrate 1002 to reach the bottom reagent deposit 1001, and further,through the bottom reagent 1001, and the pyroelectric film 1003 in orderto reach the top reagent deposit 1001.

In the arrangement of FIG. 26, a second EM source 1005 is positionedabove the top transparent substrate 1002. In this way, each reagentdeposit 1001 is operable in conjunction with an EM source positionednearby, which can efficiently and more directly convey EM energythereto.

In the alternative arrangement illustrated in FIG. 27, the system 1000provides for two additional reagent deposits 1001. Specifically, areagent deposit is provided on a top surface of the substrates 1002 andon the bottom surfaces of bottom substrates 1002. In this way, reactionswith the target analyte may occur at four different locations.

In the alternative arrangement of FIG. 28, the system 1000 employs onepyroelectric film 1003 having metallic conductive surface 1009 on a topsurface and on a bottom surface thereof. Further, each of the metallicconductive surfaces 1009 has deposited thereon a reagent deposit 1001.

In the alternative arrangement of FIG. 29, the metallic conductivesurface 1009, is replaced with thermal conductive paste 1012 applied ona top and a bottom surface of the pyroelectric film 1003. As previouslydescribed with one or more of the alternative embodiments, thearrangement includes a reagent and/or a plurality of reagents and/ordeveloper to be added prior to the sampling after additional reagentand/or developer insert 1010. The additional reagent and/or developer1010, may be applied by way of a conduit 1011 in the form of a pipette,dropper, and or other applicator.

Each of FIG. 30 and FIG. 31 is provided to illustrate yet a furthervariation of the above described embodiments. In FIG. 30, a second EMsource 1005 is used in conjunction with the two reagent deposits 1001and two metallic conductive surfaces 1009. In the arrangement of FIG.31, the system 1000 employs a thermally conductive paste 1012 applied ona top and a bottom surface of the pyroelectric film 1003. Further, asecond EM source 1005 is positioned above the top reagent deposit 1001in both FIG. 30 and FIG. 31.

Now turning to FIGS. 32-36, the system 1000 according to the presentinvention employs a reflective mirror 1013 to more efficiently convey EMenergy from an EM source 1005 to one or more reagent deposits 1001. InFIG. 32, the inventive system 1000 includes a transparent substrate 1002having a reagent deposit 1001 supported on a top surface. The system1000 further includes a pyroelectric film 1003 positioned below andspaced apart from the transparent substrate 1002. Moreover, an EM source1005 is positioned below the pyroelectric film 1003, and is operable todirect energy through the pyroelectric film 1003 and the transparentsubstrate 1002 to reach the reagent deposit 1001. In a preferredembodiment, a reflective surface 1013 comprises a reflective mirrorwhich is readily commercially available. The reflective mirror 1013 ispositioned directly above and spaced apart from the reagent deposit1001. In this arrangement, the sample fluid flow 1008 is directed abovethe transparent substrate 1002 and in between the reagent deposit 1001and the reflective mirror 1013. The reflective mirror 1013 is adaptedand positioned so as to reflect EM energy emanating from the reagentdeposit 1001, and directing this reflected EM energy back onto thereagent deposit 1001. In this way, the efficiency of the system isincreased as well as the sensitivity of the system 1000 without the needfor a second EM source.

In the alternative arrangement illustrated in FIG. 33, the pyroelectricfilm 1003 is positioned above and spaced apart from the transparentsubstrate 1002, which supports the reagent deposit 1001. Further, the EMsource 1005 is positioned below the transparent substrate 1002, and ingeneral vertical alignment with the reagent deposit 1001. In thisparticular arrangement, the reflective mirror 1013 is positioned abovethe pyroelectric film 1003 and in general vertical alignment with thereagent deposit 1001 and EM source 1005. At this position, thereflective mirror 1013 can reflect and return EM energy emanating fromthe reagent deposit 1001. Again, in this way, the efficiency of thesystem is improved as well as the sensitivity of the inventive system.

In the alternative arrangement illustrated in FIG. 34, the system 1000employs, in lieu of the transparent substrate 1002, a metallicconductive surface 1009 as described in previous embodiments. Moreover,the EM source 1005 is now located directly above and spaced apart fromthe reagent deposit 1001. Furthermore, the reflective mirror 1013 ispositioned below the pyroelectric film 1003 and in general verticalalignment with both the reagent deposit 1001 and the EM source 1005. Inthis arrangement, the mirror 1013 is positioned to reflect EM energydirected from EM source 1005 and traveling through the reagent deposit1001, the metallic conductive surface 1009, and the pyroelectric film1003. In this way, the intensity of the EM energy irradiated upon thereagent 1001 is intensified, thereby increasing the sensitivity of theinventive system 1001. FIG. 35 is a variation of the arrangement and thesystem 1000 illustrated in FIG. 34. In lieu of the metallic conductivesurface 1009, thermally conductive paste 1012 is employed in a mannersimilar to one or more of previously described embodiments.

In the arrangement illustrated in FIG. 36, the system 1000 employs atransparent substrate 1002 having a reagent deposit 1001 supported on abottom surface. In this alternative arrangement, a reflective mirror1013 is positioned below the pyroelectric film 1003, which is positionedbelow and spaced apart from the reagent deposit 1001 and transparentsubstrate 1002. As illustrated in the figure, the reflective mirrorreflects EM energy back through the pyroelectric film 1003 and upon thereagent deposit 1001.

Now turning to FIG. 37, an alternative arrangement for the inventivesystem 1000 is shown having a transparent substrate 1002 positionedabove and spaced apart from the pyroelectric film 1003. In thisparticular arrangement, the system 1000 further employs a cup orcontainer 1014 positioned on a top surface of the transparent substrate1002. A sample 1015 is provided in container 1014 for testing purposesto determine whether a target analyte is present in the sample. The cupor container 1014 may be made of a suitable material, such as glass,polypropylene, polyethylene or polyester. A reagent(s) and/or developer1010 may also be added prior to and after sampling via conduit means1011. Moreover, in this particular embodiment, the EM source 1005 ispositioned below the pyroelectric film 1003 and the transparentsubstrate 1002, but in general vertical alignment with the targetanalyte.

The alternative arrangement illustrated in FIG. 38 provides for a system1000 employing a reflective mirror 1013. The reflective mirror 1013 ispositioned above the cup or container 1014. In this way, the reflectivemirror 1013 can reflect and redirect EM energy originally conveyed fromthe EM source 1005 positioned below the pyroelectric film 1003. Such useof the reflective mirror 1013 intensifies the EM energy irradiated uponthe sample 1015, thereby increasing the sensitivity of the inventivesystem 1000.

In the alterative arrangement illustrated in FIG. 39, the system 1000employs a cup or container 1014 for retaining or holding the sample1015. The conductive cup or container 1014 is positioned directly on thepyroelectric film 1003 and in general vertical alignment with the EMsource 1005.

In the alternative arrangement illustrated in FIG. 40, the inventivesystem 1000 employs both a transparent substrate 1002 and a pyroelectricfilm 1003. The transparent substrate 1002 supports a cup or a container1014 having the sample thereon 1015, and in position to receive anadditional reagent and/or developer 1010, via a conduit means 1011.Moreover, the pyroelectric film 1003 is positioned below and spacedapart from the transparent substrate 1002 and a reflective mirror 1013is positioned below and spaced apart from the bottom surface of thepyroelectric film 1003. As shown in the Figure, the EM source 1005 ispositioned above the cup or container 1014 and in general verticalalignment with the cup or container 1014, the analyte 1015, and thereflective mirror 1013. The use of the reflective mirror 1013, in thisway, intensifies the EM energy directed upon the analyte 1015, therebyincreasing the sensitivity of the inventive system 1000.

In the arrangement illustrated in FIG. 41, the system 1000 provides acup or container 1014 having the sample 1015 therein, directly on a topsurface of the pyroelectric film 1003. Moreover, the reflective mirror1013 is positioned below and spaced apart from the pyroelectric film1003, while the EM source 1005 is positioned above and spaced apart fromthe cup or container 1014. Each of the EM sources 1005, the sample 1015retained in the cup or container 1014, and the reflective mirror 1013are in general vertical alignment, so as to intensify the EM energyirradiated upon the reagent 1015 (in a manner similar to those describedin previous embodiments).

In the arrangement illustrated in FIG. 42, the inventive system 1000employs both a transparent substrate 1002 and a pyroelectric film 1003.EM sources 1005 are positioned both below the pyroelectric film 1003 andabove the transparent substrate 1002, and in general vertical alignmentwith the cup or container 1014. The EM source 1005 can, therefore,direct EM energy through the sample 1015 from two directions.

FIG. 43 illustrates yet another alternative arrangement for theinventive system 1000. The system 1000 includes a conductive cup orcontainer 1014 positioned directly on a conductive top metallic surface1004 a of the pyroelectric film 1003. EM sources 1005 are positionedabove and below the pyroelectric film 1003 to direct EM energy throughthe reagent 1015 provided in the cup or container 1014.

In another arrangement, the inventive system employs a transparentsubstrate to support a plurality of reagent deposits, at least one ofwhich is on a top surface and the other on a bottom surface. The systemfurther employs a pyroelectric film, as previously described, positionedbelow and spaced apart from the transparent substrate and the reagentdeposit supported thereon. The illustrated system specifically utilizesthe use of fiber optic cables to convey EM energy, i.e., light from oneor more EM sources. In the illustrated arrangement, the fiber opticcable includes four separate fiber optic cables. One cable directs lightfrom the EM source to the top reagent deposit. A second cable directslight to a top surface of the transparent substrate directly above buton opposite sides of the bottom reagent deposit. The system furtherprovides two additional fiber optic cables to direct light towards thebottom metallic conductive surface of pyroelectric film. Each of thebottom fiber optic cables is positioned in general vertical alignmentwith one of the reagent deposits, so as to direct light through thepyroelectric film and in the direction of each of the reagent deposits.

In each of the previously described alternative arrangements of theinventive system 1000, a variety of additional components andaccessories may be employed to improve the performance of the system1000 or to better suit certain applications. For example, in variousapplications, a prefilter may be provided on the exterior or interior ofa badge containing or embodying the system 1000. In the furtherembodiments, the prefiltering may be provided over a membrane or layerthat covers a reagent and/or may be impregnated within the reagentitself. In yet further embodiments, filters may be provided to preventinterferent(s) from contacting the reagent on the film (which wouldotherwise contaminate the reagent). Filters may also be provided toprevent moisture from contacting the reagent or the pyroelectric film.Additional filters may be provided as well, to absorb the interferent,contaminant, or moisture.

Other components or means may be employed to improve the integrity andthus the performance of the detection system. For example, exit portsmay be provided to vent the ambient environment. Such an exit port maybe shielded to prevent moisture and/or water from entering the system.Further, when a pump is used, a replaceable charcoal filter may beprovided at the exit side of the badge and before the sample is drawnthrough the pump. The pump is preferably a modular, plug-in design thatcan be removed from a basic detection system unit, disposed of, and thenretained for use with another unit. In certain embodiments, the badgeand the pump are one integrated unit or may be separate. When the badgeand the pump are separate, the pump may be housed in a flexible clearplastic or flexible pouch of some other material that is impervious tochemical agents (e.g., for six hours to help ensure easydecontamination). The badge and/or pump may be powered by a variety ofways: batteries, re-chargeable batteries, AC power supply, DC powersupply, a hand crank or pump and spring mechanism; solar energy; and/orwind energy.

If the pump and badge are housed together or separately, a variety ofinformation may be stored in the pump or badge. These include(algorithm) software, measurement readings; display; the alarms,computer interface; memory; measurement ranges; etc.

In another aspect of certain embodiments of the system 1000, thepyroelectric film 1003 may be connected to a filter that removesspecific interferents such as anilines and amines from TDI reagent. Thepyroelectric film 1003 may be used with a variety of color codes todetect various detected agents, e.g., nerve agents, blister agents,choking agents, and blood agents. For example, nerve agent detectors maybe provided in red stripes and blister agent detectors may be providedin yellow stripes and a dot. Likewise, different detectors may belabeled with military or international markings for detecting variousdetectors.

Another component that may be advantageously integrated with the system1000 previously described, is a microprocessor or plurality ofmicroprocessors having programmed therewith a suitable algorithm andsoftware. The algorithm and software may be adapted for performingand/or controlling various functions, and may be remotely monitored,downloaded, upgraded, and processed via electronic mail and/ortelephone.

With the aid of the microprocessor, the EM source or sources mayirradiate at the same time, continuously, at intervals, or sequentially,during sampling and/or after sampling. Moreover, the EM source mayinterrogate the output of the pyroelectric film 1003 and reagent 1001 atany time from the beginning to the end of the sampling and, for anyportion of time within the sampling period. The microprocessor may bealso used to set the frequency of the interrogation based upon, forexample, time and the rate of increase or decrease in the absolutechange in the output, and from the increase or decrease in the averageoutput of previous readings compared to the most recent reading.Additionally, the frequency of interrogation may be based upon thepercentage of the full-scale range, the threshold limit value (TLV), thetime weigh average (TWA), the short term exposure limit (STEL) and/orthe permissible exposure limit (PEL). Such frequency may also be basedupon the percentage of the alarm set point, or as an absolute unit ofmeasure from the alarm set point. With the aid of the microprocessor,the system may be able to correct itself for zero drift and calibrationdrift, and for degradation of the reagent 1001 and/or the pyroelectricfilm 1003 over time, temperature range, or over humidity range. Addingto may perform this or deducting from the output of previous readings,the difference between the last reading and a factor established inlookup tables (based upon temperature, humidity, expired shelf life,exposed pressure, target analyte concentration, and any combinationthereof). An alternative algorithm may be employed that adds to ordeducts from the output of the last reading, the difference between thelast reading and the prior reading or an average of prior readings.Furthermore, the microprocessor may be used to calculate the amount orrate of change for a comparison with an alarm set point. This may bedone by comparing the current readings, in units such as ppb, ppm,percent volume, and/or percent of change in readings taken since thelast sample and then a comparison made to an alarm set point establishedas a specific number increases or decreases. This specific number may bebased in the unit volume and/or specified as specific percentageincrease or decrease in the unit volume and/or a specifiedminimum/maximum percentage increase of or decrease.

With the aid of the microprocessor, the inventive detection system maybe operable to trigger an alarm based upon the rate of change thatexceeds a set point. The alarm may include audio, visual, and vibratingalarms. Furthermore, the microprocessor may be used to record the timeand/or date of signal output in the alarm, as well as the concentrationof the target analyte. The system may also be able to store all alarms(high or low), the duration of the alarm, and the concentration of thedetected analyte.

The microprocessor also makes it possible, in a variety of ways, tomeasure more than one range or a target analyte independently ofdifferent reagents, and at different ranges. Furthermore, measurementsmay be made for more than one target analyte and for more than one rangefor each of the target analytes. In another variation of the inventivesystem, the microprocessor may be used to provide different flow ratesand/or face velocity at each reagent and/or each range of the targetanalyte. These functions may be formed simultaneously and/orsequentially. Also, different flow rates and velocities may be providedfor each reagent, and at different pressures.

Other improvements to the system may be included. For example, thereagent deposit may shift and/or increase the intensity of the reflectedEM spectrum upon biological interaction with the analyte. Alternatively,the reagent deposit may shift and or increase the intensity of thereflected EM spectrum upon physical interaction with the analyte. Thesystem may include an immunoassay sensor and method for detecting thepresence of a particular analyte comprising a solid substrate whichchanges pyroelectric properties. An antibody to which the analyte bindsimmobilized on the solid substrate may be included. A transducer surfacemay provide at least one electrophoretic separation layer. An electrodemeans provides a voltage signal indicative of heat generated on saidtransducer surface. A means of irradiation of the transducer surfacewith light frequency whereby heat is generated is included. A taggedform of the analyte displaceably binds to the antibody. It has a lowerbinding energy than an untagged analyte. The untagged analyte displacesthe tagged analyte and binds to the antibody when the antibody withtagged analyte contacts a sample containing the untagged analyte. Theantibody with bound tagged analyte has a pyroelectric property which ischanged by displacement of the tagged analyte by untagged analyte. Theantibody with bound tagged analyte forms a solid state system.

The sensor may further comprise a pyroelectric detector operativelyassociated with the solid substrate to detect changes in thepyroelectric property produced by displacement of the tagged analyte byuntagged analyte. The solid substrate of the sensor may comprise amembrane. The sensor transducer surface is transparent at a pre-selectedlight frequency so as to irradiate the antibody to which the analytebinds immobilized on the solid substrate. The antibody may be amonoclonal antibody, a pool of monoclonal antibodies, or a polyclonalantibody. The system may further comprise an immunoassay sensor andmethod based on immunochromatograpy techniques for detecting thepresence of a particular analyte and comprise a sample delivery padfunction to filter out any undesired matter and to hold analyte so thatit can slowly wick to an antibody conjugate release pad. A conjugateantibody release pad that contains pre-selected conjugated antibody tobind to analyte and migrate to analysis pad. An analysis pad holds theconjugated antibody bound analyte. A transducer surface proves at leastone electrophoretic separation layer adjacent to the analysis pad. Anelectrode means provides a voltage signal indicative of heat generatedon the transducer surface. A means of irradiation of the transducersurface with light frequency is provided to generate heat. A buffercontrols a pH balance of the sample, such as PBS. A surfactant preventsformation of aggregates, such as Triton-x-100. A means of separating theconjugate antibody release pad from the analysis pad after conjugatedantibody bound flow to the analysis pad prevents the sample from flowingback to the conjugate antibody release pad. The sensor may furthercomprise a pyroelectric detector operatively associated with theanalysis pad to detect changes in a pyroelectric property produced bydisplacement of the tagged analyte by untagged analyte. The transducersurface is transparent at a certain light frequency so as to irradiatethe conjugated antibody to which the analyte binds. The antibody may bea monoclonal antibody, a pool of monoclonal antibodies, or a polyclonalantibody.

Although the present system, apparatus and method of detecting a targetanalyte and its advantages have been described in detail, it should beunderstood that various changes, substitutions and alterations can bemade herein without departing from the spirit and scope of the inventionas defined by the appended claims. Moreover, the scope of the presentapplication is not intended to be limited to the particular embodimentsof the process, machine, manufacture, and composition of matter, means,methods and steps described in the specification. For example, variousexemplary configurations of a detection system have been described. Asone of ordinary skill in the art will readily appreciate from thedisclosure of the present invention, various elements from measurementor instrumentation technology, or measuring methods or steps, presentlyexisting or later to be developed that perform substantially the samefunction or achieve substantially the same result as the correspondingembodiments described herein may be utilized according to the presentinvention. Accordingly, the appended claims are intended to includewithin their scope such machines, apparatus, methods, or steps.

1. In a system for measuring the concentration of at least one targetanalyte, a sensor carrier subsystem comprising: a transparent substratehaving a first surface, a second surface disposed opposite of said firstsurface, and a reagent deposit supported on said first surface, saidreagent deposit being reactive to exposure to the target analyte andfurther characterized by a capacity to absorb electromagnetic energy,wherein said absorption capacity changes after said reagent depositreacts upon exposure to the target analyte such that said change incapacity is indicative of an amount of exposure to the target analyte;an electromagnetic spectrum emitting source (EM source) positionedproximal to said transparent substrate said EM source being operable toirradiate said reagent deposit by way of a path directed through saidtransparent substrate; and a pyroelectric transducer positioned proximalto said reagent deposit to detect energy absorbed by said reagentdeposit upon irradiation by said EM source and generate output signalsindicative of the detected energy, such that said output signal isindicative of exposure to the target analyte.
 2. The carrier subsystemof claim 1, wherein said pyroelectric transducer is positionedintermediate said transparent substrate and said EM source, such thatsaid EM source is operable to irradiate said reagent deposit by way of apath directed through said pyroelectric transducer and through saidtransparent substrate.
 3. The carrier subsystem of claim 1, wherein saidtransparent substrate is positioned intermediate said transducer andsaid EM source.
 4. The subsystem of claim 1, further comprising a secondEM source positioned proximal said reagent deposit such that said firstsurface is positioned intermediate said second surface and said secondEM source.
 5. The subsystem of claim 4, wherein said pyroelectrictransducer is positioned intermediate said transparent substrate andsaid second EM source, such that said second EM source is operable toirradiate said reagent deposit by way of a path directed through saidpyroelectric transducer.
 6. The subsystem of claim 5, wherein saidpyroelectric transducer is a transparent pyroelectric film.
 7. Thesubsystem of claim 1, wherein said reagent deposit is supported on saidtransparent substrate such that said reagent deposit faces and is spacedapart from said pyroelectric transducer; and wherein said transparentsubstrate and said pyroelectric transducer are spaced apart so as toprovide a sample environment flow path therebetween.
 8. The subsystem ofclaim 1, wherein said transparent substrate further includes a secondreagent deposit supported on one of said first and second surfaces. 9.The subsystem of claim 8, wherein said second reagent deposit isdisposed on said second surface in generally vertical alignment withsaid first reagent deposit supported on said first surface.
 10. Thesubsystem of claim 8, further comprising a second EM source positionedrelative to said first EM source, such that said transparent substrate,said first and second reagent deposits, and said pyroelectric transducerare positioned intermediate said first and second EM sources.
 11. Thesubsystem of claim 8, further comprising a second EM source positionedproximal said first EM source, such that said pyroelectric transducer ispositioned intermediate said transparent substrate and said first andsecond EM sources.
 12. The subsystem of claim 1, further comprising asecond substrate supporting a reagent deposit on a first surface of saidsecond substrate and spaced apart from said pyroelectric transducer suchthat said second reagent deposit faces said pyroelectric transducer,wherein said EM source is operable to irradiate said second reagentdeposit by way of a path directed through said transparent substrate andthrough said pyroelectric transducer.
 13. The subsystem of claim 1,further comprising: a second transparent substrate having a firstsurface and a second surface disposed opposite of said first surface,wherein a second reagent deposit is supported on said first surface andspaced apart from said pyroelectric transducer such that said secondreagent deposit faces said pyroelectric transducer; and a second EMsource positioned proximal said second surface of said secondtransparent substrate and operable to irradiate said second reagentdeposit by way of a path directed through said first and second surfacesof said second transparent substrate.
 14. The subsystem of claim 1,further comprising a reflective surface positioned to redirect energyemitted by said EM source to said reagent deposit, said reflectivesurface being positioned relative to said EM source such that saidtransparent substrate, said reagent deposit, and said pyroelectrictransducer are positioned intermediate said reflective surface and saidEM source.
 15. The subsystem of claim 14, wherein said reflectivesurface is a mirror spaced directly across from said reagent deposit.16. The subsystem of claim 1, wherein said pyroelectric transducerincludes pyroelectric film having conductive electrodes thereon fortransmitting an output signal.
 17. The subsystem of claim 16, whereinsaid pyroelectric film is substantially transparent to said EM energyirradiated from said EM source.
 18. The subsystem of claim 17, whereinsaid EM source is visible, UV IR light emitting source and microwavesource.
 19. The subsystem of claim 1, wherein said reagent deposit isaffecting the reflected EM spectrum upon chemical interaction with theanalyte by one or two means consisting from shifting the reflected EMspectrum and changing the intensity of the reflected EM spectrum. 20.The subsystem of claim 19, wherein said EM source is a light emittingsource and said pyroelectric transducer is adapted to detect the amountof heat absorbed in said reagent deposit upon illumination by said lightemitting source.
 21. The subsystem of claim 1, further comprising afiber optic cable operatively or light bar associated with said EMsource to direct EM energy via said path to said reagent deposit. 22.The subsystem of claim 1, wherein said reagent deposit is affecting thereflected EM spectrum upon biological interaction with the analyte byone or two means consisting from shifting the reflected EM spectrum andchanging the intensity of the reflected EM spectrum.
 23. The subsystemof claim 1, wherein said reagent deposit is affecting the reflected EMspectrum upon physical interaction with the analyte by one or two meansconsisting from shifting the reflected EM spectrum and changing theintensity of the reflected EM spectrum.
 24. The subsystem of claim 1further comprising an immunoassay sensor and method for detecting thepresence of a particular analyte comprising: a solid substrate whichchange pyroelectric properties; an antibody to which the analyte bindsimmobilized on the solid substrate; a transducer surface providing atleast one electrophoretic separation layer; an electrode means thatprovides a voltage signal indicative of heat generated on saidtransducer surface; a means of irradiation of the transducer surface byEM source whereby heat is generated; and, a tagged form of the analytedisplaceably bound to the antibody and having lower binding energy tothe antibody than untagged analyte, wherein untagged analyte willdisplace tagged analyte and bind to the antibody when the antibody withtagged analyte contacts a sample containing untagged analyte, theantibody with bound tagged analyte having pyroelectric property which ischanged by displacement of tagged analyte by untagged analyte, theantibody with bound tagged analyte forming a solid state system.
 25. Thesensor of claim 24 further comprising a pyroelectric detectoroperatively associated with the solid substrate to detect changes inpyroelectric property produced by displacement of the tagged analyte byuntagged analyte.
 26. The sensor of claim 24 wherein the solid substrateis a membrane.
 27. The sensor of claim 24 wherein the transducer surfaceis transparent at said light frequency so as to irradiate said antibodyto which the analyte binds immobilized on the solid substrate.
 28. Thesensor of claim 24 wherein the antibody is one or more selected from agroup consisting of a monoclonal antibody, a pool of monoclonalantibodies, and a polyclonal antibody.
 29. The subsystem of claim 1further comprising an immunoassay sensor and method based onimmunochromatograpy techniques for detecting the presence of aparticular analyte comprising: a conjugate antibody release pad thatcontains at least one pre-selected conjugated antibody to bind toanalyte and thereafter migrate to analysis pad; a sample delivery pad tofilter out any undesired matter and to hold analyte so that said analytecan slowly wick to the antibody conjugate release pad; an analysis padto hold the conjugated antibody bound analyte; a transducer surfaceproviding at least one electrophoretic separation layer adjacent to theanalysis pad; an electrode means that provides a voltage signalindicative of heat generated on said transducer surface; a means ofirradiation of the transducer surface with light frequency whereby heatis generated; a buffer to control a pH level of the sample; a surfactantto prevent aggregates formation; and, a means of separating saidconjugate antibody release pad from said analysis pad after a boundconjugated antibody flows to the analysis pad to prevent the sample fromflowing back to the conjugate antibody release pad.
 30. The sensor ofclaim 29 further comprising a pyroelectric detector operativelyassociated with the analysis pad to detect changes in pyroelectricproperty produced by displacement of the tagged analyte by untaggedanalyte.
 31. The sensor of claim 29 wherein the transducer surface istransparent at said light frequency so as to irradiate said conjugatedantibody to which the analyte binds.
 32. The sensor of claim 29 whereinthe antibody is one or more selected from a group consisting of amonoclonal antibody, a pool of monoclonal antibodies, and a polyclonalantibody.
 33. The systems of claim 1 wherein the EM source generatesenergy in the microwave frequency spectrum.
 34. The systems of claim 1wherein the reader contains a timer.
 35. The systems of claim 1 whereinthe reagent is reversible and reusable.
 36. The systems of claim 1wherein the reagent is non-reversible and reusable.
 37. The systems ofclaim 1 wherein the reagent is printed onto the substrate using aninkjet printer.
 38. The systems of claim 1 wherein the reagent is screenprinted onto the substrate.
 39. The systems of claim 1 wherein thereagent is cast in a mold onto the substrate such that the moldedreagent is symmetrical on the top, bottom and sides.
 40. The systems ofclaim 1 wherein the EM source is located on a removable assemblysubcomponent of the system.
 41. The systems of claim 1 wherein thefilter assembly is located on a removable assembly subcomponent of thesystem.
 42. The systems of claim 1 wherein said transparent substratecontains a memory chip.
 43. A method of detecting the presence of atarget analyte in a sample environment utilizing a reagent depositreactive to exposure to the target analyte and further characterized bya capacity to absorb electromagnetic energy irradiated thereupon,wherein the absorption capacity changes after a reaction to exposure,said method comprising the steps of: providing a transparent substratehaving a first surface, a second surface disposed opposite the firstsurface, and a reagent deposit supported on one of either the first orsecond surfaces; positioning an electromagnetic energy emitting source(EM source) relative to the transparent substrate such that the secondsurface is positioned intermediate the first surface and the EM source;positioning a pyroelectric transducer for detecting energy absorbed bythe reagent deposit proximate the reagent deposit; directing a sampleenvironment past the proximity of the reagent deposit, therebyinitiating a reaction to exposure to the target analyte in the sampleenvironment; operating the EM source to irradiate the reagent deposit byway of a path directed through the transparent substrate; and, utilizingthe pyroelectric transducer to detect the energy absorbed by the reagentdeposit upon irradiation by the EM source and generate output signalscorresponding with a measure of the detected energy, such that theoutput signal corresponds with the degree of exposure.
 44. The method ofclaim 43, wherein said step of positioning the pyroelectric transducerincludes positioning the pyroelectric transducer intermediate thetransparent substrate and the EM source, such that during the step ofoperating the EM source, the EM source irradiates the reagent deposit byway of a path through the pyroelectric film and through the transparentsubstrate.
 45. The method of claim 43, further comprising the step ofpositioning the transparent substrate intermediate the pyroelectrictransducer and EM source, prior to the step of directing the sameenvironment.
 46. The method of claim 43, further comprising the step ofpositioning a second EM source proximal the reagent deposit such thatthe first surface is positioned intermediate the second surface and thesecond EM source.
 47. The method of claim 43, further comprising thestep of providing a second substrate that supports a reagent deposit ona first surface of the second substrate and spaced apart from thepyroelectric transducer such that the second reagent deposit faces thepyroelectric transducer, wherein said step of operating the EM sourceirradiates the second reagent deposit by way of a path directed throughthe transparent substrate and through the pyroelectric transducer. 48.The method of claim 43, wherein said step of positioning thepyroelectric transducer includes positioning the pyroelectric transducerintermediate the transparent substrate and the second EM source, whereinsaid pyroelectric transducer is substantially transparent, such that, inthe step of operating the EM source, the reagent deposit is irradiatedby way of a path directed through the pyroelectric transducer.
 49. Themethod of claim 43, wherein the reagent deposit is supported on thetransparent substrate such that the reagent deposit faces and is spacedapart from the pyroelectric transducer, and wherein the transparentsubstrate and the pyroelectric transducers are spaced apart, such that,in the step of directing a sample environment, a flow stream of thesample environment is directed between the pyroelectric transducer andthe transparent substrate.
 50. The method of claim 49, wherein the EMsource is a light emitting source such that, in the step of utilizingthe pyroelectric transducer, the pyroelectric transducer detects theamount of heat absorbed in the reagent deposit upon illumination by thelight emitting source.
 51. The method of claim 43, further comprisingthe step of positioning a reflective surface relative to the EM sourcesuch that the transparent substrate, the reagent deposit, and thepyroelectric transducer are positioned intermediate the reflectivesurface and the EM source, and wherein, the step of operating the EMsource, directs energy to the reflective surface and the reflectivesurface redirects the energy to the reagent deposit.
 52. The method ofclaim 43, wherein the reagent deposit is selected from a group of one ormore of a colorimetric reagent deposit, flurecent reagent deposit andluminescent reagent deposit such that in the step of directing thesample environment, the reagent deposit changes upon exposure to thetarget analyte.
 53. A system for detecting the presence of at least onetarget analyte in a sample local environment, said system comprising: atransparent substrate having a first surface, a second surface disposedopposite of said first surface, and a reagent deposit supported on saidfirst surface, said reagent deposit being reactive to exposure to thetarget analyte and further characterized by a capacity to absorbelectromagnetic energy, wherein said absorption capacity changes aftersaid reagent deposit reacts upon exposure such that said change incapacity is indicative of the exposure to the target analyte; anelectromagnetic spectrum emitting source (EM source) positioned proximalto said transparent substrate and closer to the second surface than tothe first surface, said EM source being operable to irradiate saidreagent deposit by way of a path directed through said transparentsubstrate; a pyroelectric transducer positioned proximal to said reagentdeposit to detect energy absorbed by said reagent deposit uponirradiation by said EM source and generate output signals indicative ofthe detected energy, such that said output signal is indicative ofexposure to the target analyte; and a reader operatively associated withsaid pyroelectric transducer to receive said output signals, andcommunicate, therefrom, an indication of the presence of the targetanalyte in the sample local environment.
 54. The system of claim 53,wherein said pyroelectric transducer is positioned intermediate saidtransparent substrate and said EM source, such that said EM source isoperable to irradiate said reagent deposit by way of a path directedthrough said pyroelectric transducer and through said transparentsubstrate.
 55. The carrier subsystem of claim 53, wherein saidtransparent substrate is positioned intermediate said transducer andsaid EM source.
 56. The system of claim 53, further comprising a secondEM source positioned proximal said reagent deposit such that said firstsurface is positioned intermediate said second surface and said secondEM source.
 57. The system of claim 56, wherein said pyroelectrictransducer includes a transparent pyroelectric film positionedintermediate said transparent substrate and said second EM source, suchthat said second EM source is operable to irradiate said reagent depositby way of a path directed through said pyroelectric transducer.
 58. Thesystem of claim 53, wherein said reagent deposit is colorimetricallyreactive to a target analyte and said EM source is a light emittingdiode.
 59. The system of claim 53, wherein said reagent deposit issupported on said transparent substrate such that said reagent depositfaces and is spaced apart from said pyroelectric transducer and whereinsaid transparent substrate and said pyroelectric transducer are spacedapart so as to provide a sample environment flow path therebetween. 60.The system of claim 53, wherein said transparent substrate furtherincludes a second reagent deposit supported on said second surface anddisposed on said second surface in generally vertical alignment withsaid first reagent deposit supported on said first surface.
 61. Thesubsystem of claim 53, further comprising a second substrate supportinga reagent deposit on a first surface of said second substrate and spacedapart from said pyroelectric transducer such that said second reagentdeposit faces said pyroelectric transducer, wherein said EM source isoperable to irradiate said second reagent deposit by way of a pathdirected through said transparent substrate and through saidpyroelectric transducer.
 62. The systems of claim 53 wherein the EMsource generates energy in the microwave frequency spectrum.
 63. Thesystems of claim 53 wherein the reader contains a timer.
 64. The systemsof claim 53 wherein the reagent is reversible and reusable.
 65. Thesystems of claim 53 wherein the reagent is non-reversible and reusable.66. The systems of claim 53 wherein the reagent is printed onto thesubstrate using an inkjet printer.
 67. The systems of claim 53 whereinthe reagent is screen printed onto the substrate.
 68. The systems ofclaim 53 wherein the reagent is cast in a mold onto the substrate suchthat the molded reagent is symmetrical on the top, bottom and sides. 69.The systems of claim 53 wherein the EM source is located on a removableassembly subcomponent of the system.
 70. The systems of claim 53 whereinthe filter assembly is located on a removable assembly subcomponent ofthe system.
 71. The systems of claim 53 wherein said transparentsubstrate contains a memory chip.
 72. A system for detecting a targetanalyte comprising: a transparent substrate having a first surface, asecond surface disposed opposite said first surface and a reagentdeposit supported on at least one of said first and second surfaces,said reagent deposit being reactive to exposure to a target analyte tochange a capacity to absorb electromagnetic energy; a means for moving asample of a local environment across the transparent substrate to causea change in the capacity of the reagent deposit to absorbelectromagnetic energy when the sample of the local environment includesthe target analyte; a piezoelectric reader that includes a light sourcefor emitting light onto said reagent deposit and a means for measuring achange in the capacity of the reagent deposit to absorb electromagneticenergy; an indicator means coupled to the piezoelectric reader meansthat indicates detection of the target analyte; and, a control mechanismfor controlling the means for moving a sample of the local environmentacross the transparent substrate.
 73. The system of claim 72 furthercomprising: an indicator means consisting of one or more selected from adigital display, a visual alarm, an audible alarm or a vibrating alarm.74. The system of claim 72 wherein said means from moving a sample of alocal environment comprises a pump.
 75. The system of claim 74 furthercomprising: a flow regulator for controlling an amount of sample movedacross the transparent substrate; and, flow meter for measuring theamount of sample moved across the transparent substrate.
 76. The systemof claim 72 further comprising a filter coupled to said means frommoving a sample of a local environment.
 77. The system of claim 72further comprising one or more environmental sensors selected from agroup consisting of a temperature sensor, a pressure sensor and ahumidity sensor.
 78. The system of claim 72 wherein said transparentsubstrate comprises a cartridge including multiple reagents that testsfor at least one target analyte.
 79. The systems of claim 72, whereinthe EM source generates energy in the microwave frequency spectrum. 80.The systems of claim 72 wherein the reader contains a timer.
 81. Thesystem of claim 74 wherein the flow control of the pump is comprised ofan orifice in the flow path of the system.
 83. The system of claim 74wherein the flow control of the pump is controlled by the motor speed.84. The system of claim of 74 wherein the reading from the transducer isused as a baseline and subtracted from subsequent readings such that anon-reversible reagent becomes reusable for multiple readings.
 85. Thesystem of claim 75 wherein a maximum point of exposure relating tosaturation of the reagent is pre-stored in memory.
 86. The systems ofclaim 72 wherein the reagent is reversible and reusable.
 87. The systemsof claim 72 wherein the reagent is non-reversible and reusable.
 88. Thesystems of claim 72 wherein the reagent is printed onto the substrateusing an inkjet printer.
 89. The systems of claim 72 wherein the reagentis screen printed onto the substrate.
 90. The systems of claim 72wherein the reagent is cast in a mold onto the substrate such that themolded reagent is symmetrical on the top, bottom and sides.
 91. Thesystems of claim 72 wherein the EM source is located on a removableassembly subcomponent of the system.
 92. The systems of claim 72 whereinthe filter assembly is located on a removable assembly subcomponent ofthe system.
 93. The systems of claim 72 wherein said transparentsubstrate contains a memory chip.